A RANDOMIZED CLINICAL TRIAL TO COMPARE APAMARGA SADHYAKSHARASUTRA AND CONVENTIONAL APAMARGA KSHARASUTRA IN UNIT CUTTING TIME OF FISTULOUS TRACT
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- unit cutting time
研究概览
简要总结
The present study is undertaken to overcome and compare the limitations of the
conventional ksharasutras with sadyaksharasutra, like difficulty in the preparation and
preservation of ksharasutra, prolonged cutting time and long standing severe pain
following ksharasutra application. As surgery is considered essential in many cases of
fistula-in-ano, but due to increased chances of recurrence, ksharasutra becomes their
last resort. The main objective of the present study is to attain a fast cutting time with
minimal complications and to shorten the whole treatment duration. Kshara is prepared
from Apamarga (Achyranthes aspera) . As Apamarga kshara is used for making
sadyaksharasutra, it is beneficial in two ways, one by not developing any skin irritation
/ allergic reactions and the other by improving cutting along with healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Diagnosed cases of fistula-in-ano.
- •â€¢ Single tract fistula.
- •â€¢ Both high and low anal fistula.
排除标准
- •Uncontrolled diabetes mellitus, hypertension and other known systemic illnesses.
- •â€¢ Fistula without external opening • Fistula secondary to systemic diseases (tuberculosis, Crohn’s disease, ulcerative colitis, PCOD, metabolic disorders) with multiple tract.
- •â€¢ Bleeding disorders, HIV, HBsAg, contagious diseases and carcinomas.
结局指标
主要结局
unit cutting time
时间窗: 28th day
次要结局
- pain(every 3rd day for 1month)